MAUDE Adverse Event Report: A&E MEDICAL CORPORATION UFM W 16MM 3/8CIR 64MM KN 24PK; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that the patient underwent a cardiac procedure and temporary pacing wires were placed.About a month later the atrial leads were pulled out of body during radiographs.It was noted the only left ventricular wires were in place.The frayed ventricular leads appeared as though they could fracture at any point.A revision procedure is planned to replace the temporary pacing wires and permanent wires will be placed at a later date.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D2: device product code: ldh.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10 d2: product code : ldh no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section b4, b5, g3, g6, h2, h4, h6 and h10.Corrections are in sections: a1, a2, a3, a4, a5, e1, and e3.A4: patient weight: (b)(6)(b)(6)2023.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
It is further reported that the wires fray and break away from the metal contacts.Pacing and capture fail.The wires are fragile.The fraying is taking place within three days of use.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section a2, a3, b4, b5, d4, e4, g2, g3, g6, h2, h3, h4, h6 and h10.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D2: device product code: ldf review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the of this report.

• Brand Name: UFM W 16MM 3/8CIR 64MM KN 24PK
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17278404
• Report Number: 0002242056-2023-00022
• Device Sequence Number: 17423686
• Product Code: LDF
• UDI-Device Identifier: 10841291100263
• UDI-Public: (01)10841291100263(10)03363(17)271001
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K803086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/16/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 024-311
• Device Lot Number: 03363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 07/26/2023; 07/24/2023; 08/24/2023; 10/04/2023; 04/11/2024
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 07/28/2023; 08/22/2023; 09/18/2023; 11/01/2023; 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 MO
• Patient Sex: Male
• Patient Weight: 6 KG
• Patient Race: American Indian Or Alaskan Native